MedTrace Logo

"Hyaluronan" Formulation for Type 2 Diabetic Patients With Dry Mouth

NCT03281486 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-08-10

No results posted yet for this study

Summary

An increased incidence of dental caries in association with poorly controlled diabetes has also been reported, Xerostomia (dry mouth) has been reported to be a common complaint of patients with diabetes, Without adequate saliva production, both hard and soft tissues of the mouth can be severely damaged and become more susceptible to infections. This 9 week, cross-over group, randomized, single center, study will evaluate the efficacy of HA formulation in alleviating dry mouth in type 2 diabetic patients.

Conditions

Interventions

DEVICE

HA formulation Oral Spray

It is an HA formulation of FDA listed ingredients

DEVICE

Placebo

Placebo formulation without the active ingredients

Sponsors & Collaborators

  • You First Services

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-28
Primary Completion
2019-10-31
Completion
2019-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03281486 on ClinicalTrials.gov